The known processes of sterilizing an artificial organ, for example an artificial kidney, includes the step of filling such artificial organ with an aqueous solution of a sterilizer, such as formalin, or the step of filling said artificial organ with a sterilizing gas of, for example, ethylene oxide. Since the sterilizer is harmful to the human body, the prior art process of sterilizing an artificial organ makes it necessary to wash the interior of an artificial organ before it is applied to the human body. In this case, various difficulties arise that where a solution of a sterilizer, for example, formalin filled in an artificial organ is replaced by a physiological sodium chloride solution, then formaldehyde is left, and moreover harmful substances such as chlorohydrin are produced, and complete elimination of a sterilizer, for example, involves a great deal of time and work. Consequently, the conventional process of sterilizing an artificial organ has not been regarded as satisfactory.
To avoid the above-mentioned problems, a process has been proposed which comprises fully filling the interior of an artificial organ with a physiological sodium chloride solution, instead of applying any of the abovementioned chemical sterilizers and sterilizing the artificial organ with pressure and heat in an autoclave. However, this proposed sterilizing process still has the drawbacks that the artificial organ tends to be cracked or broken due to the thermal expansion of the physiological sodium chloride solution filled in the artificial organ; and these difficulties have to be resolved, before said proposed sterilizing process can be satisfactorily put to practical use.
Processes proposed to date for resolution of the aforementioned problems include, for example, the step of conducting a cannula-bearing buffer bag through the blood port or dialyzate port of an artificial organ, sterilizing the artificial organ under such condition in an autoclave, removing the buffer bag after sterilization, packing the sterilized artificial organ in a wrapper, and again sterilizing the wrapped artificial organ with an ethylene oxide gas. Another proposed process comprises fitting a deformable bag-shaped cap to the blood port or dialyzate port of an artificial organ, sterilizing the artificial organ under such condition in an autoclave, removing the bag-shaped cap, fitting the ordinary rubber cap instead, and packing the assembly in an aseptic atmosphere. However, the above-mentioned proposed processes have the drawbacks that steps extending from the sterilization of an artificial organ in an autoclave to the production of a sterilized packed artificial organ are complicated and consume a great deal of time and work, and further during the aftertreatment following sterilization, the artificial organ is likely to be again contaminated by septic or other harmful microbes. With the former proposed artificial organ-sterilizing process based on the application of a cannula-bearing buffer bag, that portion of an artificial organ which is pierced by a cannula tends to be contaminated, for example, by molds, or bacteria. With the latter proposed artificial organ-sterilizing process based on the application of a bag-shaped cap, tremendous difficulties are encountered in replacing the bag-shaped cap with the ordinary cap and packing a sterilized artificial organ in an aseptic condition. With the above-mentioned proposed artificial organ-sterilizing processes, an artificial organ sterilizer in an autoclave is cooled by water before said organ is packed in the succeeding step. Therefore, care should be taken against the possible contamination of the artificial organ during the water-cooling step.
This invention has been accomplished in view of the above-mentioned circumstances, and is intended to provide an artificial organ and a method of sterilizing the same which is adapted for sterilization with heat and pressure, for example, in an autoclave. Thus, it eliminates the necessity of an aftertreatment of the sterilized artificial organ, and prominently facilitates the connection of the artificial organ, for example, to a blood circuit.